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The ALTA Anterior Cervical Corpectomy Spacer is indicated for vertebral body replacement in the cervical spine (C3-C7) in skeletally mature patients. The Alta Anterior Cervical Corpectomy Spacer is intended to replace a diseased or damaged vertebral body caused by fracture, osteomyelitis, or tumor, or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. The System is intended to be used with supplemental fixation that has been cleared by the FDA for use in the cervical spine. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft as an adjunct to fusion. The System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectance is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.

The ALTA Anterior Cervical Corpectomy Spacer is a vertebral body replacement system manufactured from PEEK-OPTIMA LT120HA (HA PEEK) or titanium alloy (Ti6Al4VELI). The devices have trapezoidal footprints and multiple sizes to accommodate patient anatomy and graft windows to help facilitate bony integration. The HA PEEK spacers have unidirectional teeth on both of their inferior and superior surfaces to prevent migration/expulsion and X-ray markers in the form of tantalum pins. The titanium alloy spacers have roughened superior and inferior surfaces to prevent migration/expulsion.

The provided text describes a 510(k) premarket notification for a medical device, the ALTA Anterior Cervical Corpectomy System. It is a submission for substantial equivalence to legally marketed predicate devices, not for a new AI/ML-based diagnostic or assistive technology requiring extensive clinical performance studies with human readers.

Therefore, many of the requested details, such as "acceptance criteria for device performance" in the context of an AI study, sample sizes for test sets in an AI context, expert ground truth establishment, MRMC studies, or training set details, are not applicable to this specific submission as it pertains to a physical orthopedic implant device.

The relevant information from the document pertains to the device's physical and mechanical performance, not its diagnostic or interpretative accuracy.

Here's a breakdown of the applicable information based on the provided document, addressing the relevant parts of your request and noting what is not applicable:

1. A table of acceptance criteria and the reported device performance

Since this is a physical implant, the "acceptance criteria" are related to mechanical and material properties, and the "reported device performance" refers to the results of non-clinical (bench) testing.

2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: This is not applicable in the context of an AI/ML test set. For physical device testing, "samples" refer to the number of devices or test coupons subjected to mechanical testing. The document states "The following analyses were conducted," implying standard mechanical testing as per the ASTM standards. The exact number of test samples (e.g., number of implants tested per condition for compression, torsion, subsidence) is not explicitly provided in this summary but would be detailed in the full test reports referenced by the ASTM standards.
• Data Provenance: Not applicable in the context of clinical patient data as no clinical studies were performed. The "data" comes from bench testing of the physical devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• This question is not applicable. The "ground truth" for a physical orthopedic implant is established by engineering specifications, material standards, and biomechanical testing standards (e.g., ASTM F2077, ASTM F2267). It does not involve human expert consensus on medical images or diagnoses.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly for establishing ground truth by reconciling discrepancies among human readers/experts. For a physical device's mechanical testing, there is no such adjudication process.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• This question is not applicable. An MRMC study is relevant for evaluating the performance of diagnostic devices or AI algorithms that assist human interpretation. This submission is for a physical implant, not a diagnostic or AI-assisted system.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• This question is not applicable. This refers to the performance of an AI algorithm in isolation. The product is a physical implant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• For the non-clinical testing of this physical device, the "ground truth" is defined by engineering specifications, material properties, and relevant ASTM (American Society for Testing and Materials) standards (e.g., ASTM F2077 for compression/torsion and ASTM F2267 for subsidence) which dictate acceptable performance characteristics for spinal implants.

8. The sample size for the training set

• This question is not applicable. There is no "training set" as this is not an AI/ML device.

9. How the ground truth for the training set was established

• This question is not applicable. There is no "training set."

Summary of Device Performance Study:

The study proving the device meets its acceptance criteria is a non-clinical bench testing program.

• Tests Conducted: Static and dynamic compression per ASTM F2077, Static and dynamic torsion per ASTM F2077, and Subsidence per ASTM F2267.
• Results: The results of these evaluations indicated that the ALTA Corpectomy implants are equivalent to predicate devices.
• Clinical Studies: No clinical studies were performed as substantial equivalence was demonstrated through non-clinical testing and comparison to legally marketed predicate devices.

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Tranquil-CTM Interbody System

The Tranquil-C™ Interbody System is intended for use for anterior cervical interbody fusion in skeletally mature patients with cervical disc degeneration and/or cervical instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, and/or pain at multiple contiguous levels from C2 – T1. The Tranquil-C™ Interbody System is also to be used with supplemental fixation systems that have been cleared for use in the cervical spine. The Tranquil-C™ Interbody System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.

Tranquil-LTM Interbody System

The Tranquil-L™ Interbody System is intended for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 – S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radios. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. The device must be used with supplemental fixation. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). It is indicated to be used with autograft bone and/or allograft bone comprised of cancellous and/or corticocancellous bone.

The Tranquil™ Interbody System is made of Ti-6Al-4V ELI. The implant is offered in various angles, widths, heights, and lengths to meet patient anatomy for both cervical and lumbar spine. The devices and instruments are provided clean and non-sterile for steam sterilization at the user's facility.

The purpose of this traditional 510(k) is to expand the indications for use to include use with either autograft and/or allograft bone for the Tranquil™ Interbody System, as well as update the fusion level for the Tranquil-C™ Interbody System to include use at multiple levels (e.g., up to 4 levels) from C2 – T1, and add additional footprints.

The provided document is a 510(k) clearance letter from the FDA for the Tranquil™ Interbody System. It details the device's intended use and compares it to predicate devices to establish substantial equivalence. However, this document does not contain information about acceptance criteria, a specific study proving the device meets those criteria, or any of the detailed aspects of a clinical study or performance evaluation that would typically involve human readers, ground truth, or sample sizes for testing and training sets.

The only "performance data" mentioned is:

• "Mechanical performance testing data was provided as part of the previous submission to establish substantial equivalence for its use."
• "As was demonstrated in this submission through engineering rationale, the additional footprints do not present a new worst case for the testing that was previously performed. Therefore, no new mechanical testing was performed for this 510(k) submission."

This indicates that the submission relies on bench testing and engineering rationale to demonstrate that the expanded indications and additional footprints do not alter the substantial equivalence established by previous mechanical testing. There is no mention of a study involving human subjects or AI performance.

Therefore, I cannot fulfill the request for information regarding acceptance criteria and a study that proves the device meets them because that information is not present in the provided text. The document focuses on regulatory clearance based on substantial equivalence to predicate devices, primarily through engineering and material comparisons, not clinical performance studies.

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